Biological valve for venous insufficiency

Abstract

A bioprosthetic valve for repairing a deep venous insufficiency in a subject includes a single leaflet from a xenogeneic heart valve attached at natural margins of attachment to a patch of valve wall tissue. The patch may extend axially above and below the leaflet and circumferentially on either side of the leaflet to provide a region for attaching the patch to a fenestration in a host vein. A bioprosthetic valve may be manufactured by excising a portion of a xenogeneic heart valve including a single leaflet and contiguous wall tissue, and may further comprise shaving off excess leaflet tissue from adjacent leaflets. A method of replacing a malfunctioning venous valve in a subject includes providing a bioprosthetic valve as described above and inserting it to the host vein.

What is claimed is: 
     
       1. A method to repair deep vein insufficiencies, comprising the steps of:
 creating a fenestration in a host vein in the region of a malfunctioning valve, wherein the fenestration has a shape corresponding to a patch for a replacement valve; and 
 closing the fenestration after forming a monocusp venous valve using a patch of contiguous tissue, 
 wherein said patch is excised from a patch of contiguous xenogeneic heart valve tissue comprising the natural sinus, and wherein the patch of contiguous xenogeneic heart valve tissue comprising the natural sinus is configured so that the natural sinus provides a spatial buffer between a free edge of the noncoronary leaflet and a valve wall that facilitates opening and closing of the noncoronary leaflet based on flow pressure through the valve. 
 
     
     
       2. The method of  claim 1 , further comprising the step of removing at least one leaflet from a malfunctioning valve of the host vein. 
     
     
       3. The method of  claim 2  further comprising the step of forming the monocusp venous valve at the fenestration where the malfunctioning valve of the host vein is removed. 
     
     
       4. The method of  claim 1 , where the shape of the patch is oval. 
     
     
       5. The method of  claim 1 , where the shape of the patch is rectangular. 
     
     
       6. The method of  claim 1 , further comprising the step of forming the monocusp venous valve from a patch of tissue from the host vein. 
     
     
       7. The method of  claim 1 , wherein the monocusp venous valve is selected to contain significant amounts of collagen and elastin with minimal smooth muscle tissue. 
     
     
       8. The method of  claim 2  wherein the monocusp venous valve is selected to contain significant amounts of collagen and elastin with minimal smooth muscle tissue. 
     
     
       9. The method of  claim 1 , further comprising attaching a backing liner, conduit or tube to the monocusp venous valve. 
     
     
       10. The method of  claim 2 , further comprising attaching a backing liner, conduit or tube to the monocusp venous valve. 
     
     
       11. The method of  claim 1 , further comprising the step of attaching a patch to a monocusp venous valve that comprises a leaflet from the host vein. 
     
     
       12. The method of  claim 1 , wherein the patch of contiguous xenogeneic heart valve tissue comprising the natural sinus is subjected to a fixation treatment. 
     
     
       13. The method of  claim 1 , wherein the patch of contiguous xenogeneic heart valve tissue comprising the natural sinus is configured so the free edge contacts the opposite wall of the host vein. 
     
     
       14. The method of  claim 1 , wherein the patch of contiguous xenogeneic heart valve tissue comprising the natural sinus is configured so the free edge does not contact the opposite wall of the host vein. 
     
     
       15. The method of  claim 1 , wherein the fenestration extends through less of the vein circumference. 
     
     
       16. The method of  claim 1 , further comprising:
 creating a second fenestration opposite to the fenestration in the host vein in the region of the malfunctioning valve, wherein the second fenestration has a shape corresponding to a patch for a second replacement valve; and 
 closing the second fenestration after forming a second monocusp venous valve using a second patch of contiguous tissue, 
 wherein the two monocusp venous valves form a bicuspid venous valve. 
 
     
     
       17. The method of  claim 16 , wherein said second patch is excised from a second patch of contiguous xenogeneic heart valve tissue comprising the natural sinus, and wherein the second patch of contiguous xenogeneic heart valve tissue comprising the natural sinus is configured so that the natural sinus provides a spatial buffer between a free edge of the noncoronary leaflet and a valve wall that facilitates opening and closing of the noncoronary leaflet based on flow pressure through the valve. 
     
     
       18. The method of  claim 17 , wherein the two monocusp venous valves are arranged with circumferential gaps between the two valves. 
     
     
       19. The method of  claim 17 , further comprising the step of forming the second monocusp venous valve from a patch of tissue from the host vein. 
     
     
       20. The method of  claim 17 , further comprising attaching a backing liner, conduit or tube to the second monocusp venous valve.